AsthmaPhase 1NCT00659659
A Study to Evaluate the Safety, Tolerability and Effects of MEDI-563 in Adults With Asthma
A Phase 1 study testing MEDI-563 in people with Asthma, run by MedImmune LLC at 11 sites in 2 countries.
Trial summary
Evaluate the safety and tolerability of MEDI-563 in adults with asthma and the effects of MEDI-563 on eosinophil counts in airway mucosal biopsies Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- MEDI-563
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Jan 2008to Mar 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female adults, 18 through 65 years of age at time of randomization;
- Written informed consent obtained from the subject prior to beginning study procedures or receipt of any study medication;
- Previously documented diagnosis of asthma of ≥ 1 year duration, based on episodic symptoms of airflow obstruction; post-bronchodilator reversibility of airflow obstruction ≥ 12% (in USA only - if subject does not achieve this during screening, proof of ≥12% reversibility within 1 year of randomization is acceptable) or proof of a positive response to a methacholine challenge during screening with prior approval from MedImmune (in USA only - within 1 year of randomization is acceptable) as represented by a provoking concentration of methacholine to cause a 20% fall in FEV1 (PC20) < 8 mg/ml [American Thoracic Society (ATS), 2000)]; and exclusion of alternative pulmonary diagnoses (eg, cystic fibrosis, COPD);
- Asthma symptoms are adequately controlled on a therapeutic regimen that has not changed in the last 4 weeks prior to Study Day 0, and the subject is willing to maintain the same therapeutic regimen and doses from the time of screening to the time of the first follow-up bronchoscopy with airway mucosal biopsies (Study Day 28 for Cohort 1; Study Day 84 for Cohort 2);
- Pre-bronchodilator FEV1/forced vital capacity (FVC) ratio that is below the age-adjusted normal limit as defined by the 2007 National Heart Lung and Blood Institute Asthma guidelines (Appendix D) and post-bronchodilator FEV1 ≥ 65% at screening;
- Must have ≥ 2.5% eosinophils in sputum;
Show all 11Show fewer
- Have had no hospitalizations due to asthma in the last year prior to screening;
- Women of childbearing potential, unless surgically sterile or at least 1 year post-menopausal, must use 2 effective methods of avoiding pregnancy
- Able to complete the follow-up period as required by the protocol;
- Willing to forego other forms of experimental treatment and study procedures during the study and during an 84-day period after the last dose of study drug;
- Able to provide spirometric readings that meet ATS standards
Who cannot join
- Participation in any previous MEDI-563 clinical study;
- Known history of allergy or adverse reactions to any component of the study drug formulation;
- Lung disease other than asthma (eg, COPD, cystic fibrosis, eosinophilic pneumonia);
- Current use of any systemic or inhaled immunosuppressive drugs [oral (up to a maximum dose of 10 mg/day or 20 mg every other day) and inhaled corticosteroids are allowed if dose has been stable for at least 4 weeks prior to study drug administration on Study Day 0].
- Current use of any β-blocker (eg, propranolol);
- Acute illnesses or evidence of clinically significant active infection, such as fever ≥ 38.0ºC (100.5ºF) at screening and through the time of the study drug administration on Study Day 0;
Show all 19Show fewer
- Receipt of any investigational drug therapy, intravenous immunoglobulin (IVIG), or monoclonal therapy (eg, Xolair) within 30 days or within 5-half lives prior to study drug administration on Study Day 0 through End of Study/Study Termination (Study Day 84 for Cohort 1 or Study Day 140 for Cohort 2);
- Pregnancy (women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to study drug administration on Study Day 0);
- Breastfeeding or lactating;
- History of alcohol or drug abuse < 1 year prior to Study Day 0;
- History of cancer, apart from basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy > 1 year prior to Study Day 0;
- History of a previous episode of active TB or a positive TB skin test without completion of an appropriate course of treatment;
- A history of coagulation disorders that would contraindicate mucosal biopsies;
- History of immunodeficiency or infection with HIV-1, HIV-2, or hepatitis A, B, or C virus;
- History of use of tobacco products within 2 years of baseline (Study Day 0) or history of smoking ≥ 10 pack-years;
- Elective surgery planned from the time of screening through first follow-up bronchoscopy with airway mucosal biopsies (Study Day 28 or Study Day 84, as applicable);
- Evidence of any systemic disease or respiratory disease (other than asthma), history of any disease, or any finding upon physical examination, screening laboratory test, chest X-ray (CXR), or ECG that, in the opinion of the investigator or medical monitor, may compromise the safety of the subject in the study or confound the analysis of the study results;
- Any employee of the research site who is involved with the conduct of the study;
- History of lidocaine allergy
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States6 sites
Research Site
Denver, Colorado, 80206
Research Site
Galveston, Texas, 77555-0561
Research Site
Houston, Texas, 77030
Research Site
Houston, Texas
Research Site
Madison, Wisconsin, 53792
Research Site
Pittsburgh, Pennsylvania, 15213
Canada5 sites
Research Site
Calgary, Alberta, T2N4N1
Research Site
Hamilton, Ontario, L8N3Z5
Research Site
Montreal, Quebec, H2X 2P4
Research Site
Québec, Quebec, G1V4G5
Research Site
Vancouver, British Columbia
About this study
Official title: A Phase 1, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Effects of MEDI-563, A Humanized Anti-Interleukin-5 Receptor Alpha Monoclonal Antibody, on Airway Eosinophils in Adults With Atopic Asthma
Evaluate the safety and tolerability of MEDI-563 in adults with asthma and the effects of MEDI-563 on eosinophil counts in airway mucosal biopsies
Read the detailed description
Evaluate the safety and tolerability of MEDI-563 in adults with atopic asthma; and evaluate the effects of MEDI-563 on eosinophil counts in airway mucosal biopsies 28 days after completion of dosing in adults with atopic asthma.
- Conditions
- Asthma
- Being tested
- MEDI-563, Placebo Comp., Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI-563Drug
1.0 mg/kg IV: MEDI-563
MEDI-563Drug
100 mg, 200 mg SC
Placebo Comp.Other
Placebo SC
PlaceboOther
Placebo as a single IV infusion (Certain number of subjects)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MEDI-563 Receives: Drug: MEDI-563 |
| 2 | Experimental | MEDI-563 Receives: Drug: MEDI-563 |
| 4 | Placebo comparator | Placebo Receives: Other: Placebo Comp. |
| 5 | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and tolerability of MEDI-563 in adults with atopic asthma and evaluate the effects of MEDI-563 on eosinophil counts in airway mucosal biopsies 28 days after completion of dosing in adults with atopic asthma.
Measured: Study Day 84 or Day 140 - (dose-driven)
Secondary outcomes (1)
Evaluate the pharmacokinetics (PK) of MEDI-563 in adults with atopic asthma, and evaluate the immunogenicity (IM) of MEDI-563 in adults with atopic asthma.
Measured: Day 84 or 140
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Gossage, M.D., MBA, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00659659
- Sponsor's protocol ID
- MI-CP166
- Status last verified
- Oct 2012
- First submitted
- 11 Apr 2008
- Last updated
- 10 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Chachi L, Diver S, Kaul H, Rebelatto MC, Boutrin A, Nisa P, Newbold P, Brightling C. Computational modelling prediction and clinical validation of impact of benralizumab on airway smooth muscle mass in asthma. Eur Respir J. 2019 Nov 14;54(5):1900930. doi: 10.1183/13993003.00930-2019. Print 2019 Nov. No abstract available.
PubMed 31391226
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Effects of MEDI-563, A Humanized Anti-Interleukin-5 Receptor Alpha Monoclonal Antibody, on Airway Eosinophils in Adults With Atopic Asthma
- ClinicalTrials.gov ID
- NCT00659659
- Acronym / sponsor ID
- MI-CP166
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 16 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the safety and tolerability of MEDI-563 in adults with asthma and the effects of MEDI-563 on eosinophil counts in airway mucosal biopsies
Detailed description
Evaluate the safety and tolerability of MEDI-563 in adults with atopic asthma; and evaluate the effects of MEDI-563 on eosinophil counts in airway mucosal biopsies 28 days after completion of dosing in adults with atopic asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MEDI-563MEDI-563 |
| 2 | Experimental | Drug: MEDI-563MEDI-563 |
| 4 | Placebo comparator | Other: Placebo Comp.Placebo |
| 5 | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female adults, 18 through 65 years of age at time of randomization;
- Written informed consent obtained from the subject prior to beginning study procedures or receipt of any study medication;
- Previously documented diagnosis of asthma of ≥ 1 year duration, based on episodic symptoms of airflow obstruction; post-bronchodilator reversibility of airflow obstruction ≥ 12% (in USA only - if subject does not achieve this during screening, proof of ≥12% reversibility within 1 year of randomization is acceptable) or proof of a positive response to a methacholine challenge during screening with prior approval from MedImmune (in USA only - within 1 year of randomization is acceptable) as represented by a provoking concentration of methacholine to cause a 20% fall in FEV1 (PC20) < 8 mg/ml [American Thoracic Society (ATS), 2000)]; and exclusion of alternative pulmonary diagnoses (eg, cystic fibrosis, COPD);
- Asthma symptoms are adequately controlled on a therapeutic regimen that has not changed in the last 4 weeks prior to Study Day 0, and the subject is willing to maintain the same therapeutic regimen and doses from the time of screening to the time of the first follow-up bronchoscopy with airway mucosal biopsies (Study Day 28 for Cohort 1; Study Day 84 for Cohort 2);
- Pre-bronchodilator FEV1/forced vital capacity (FVC) ratio that is below the age-adjusted normal limit as defined by the 2007 National Heart Lung and Blood Institute Asthma guidelines (Appendix D) and post-bronchodilator FEV1 ≥ 65% at screening;
Key exclusion criteria (19 listed)
- Participation in any previous MEDI-563 clinical study;
- Known history of allergy or adverse reactions to any component of the study drug formulation;
- Lung disease other than asthma (eg, COPD, cystic fibrosis, eosinophilic pneumonia);
- Current use of any systemic or inhaled immunosuppressive drugs [oral (up to a maximum dose of 10 mg/day or 20 mg every other day) and inhaled corticosteroids are allowed if dose has been stable for at least 4 weeks prior to study drug administration on Study Day 0].
- Current use of any β-blocker (eg, propranolol);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEDI-5631.0 mg/kg IV: MEDI-563 | Drug | 1 |
| MEDI-563100 mg, 200 mg SC | Drug | 2 |
| Placebo Comp.Placebo SC | Other | 4 |
| PlaceboPlacebo as a single IV infusion (Certain number of subjects) | Other | 5 |
Primary outcome
Evaluate the safety and tolerability of MEDI-563 in adults with atopic asthma and evaluate the effects of MEDI-563 on eosinophil counts in airway mucosal biopsies 28 days after completion of dosing in adults with atopic asthma.
Time frame: Study Day 84 or Day 140 - (dose-driven)
1 secondary outcome
Evaluate the pharmacokinetics (PK) of MEDI-563 in adults with atopic asthma, and evaluate the immunogenicity (IM) of MEDI-563 in adults with atopic asthma.
Time frame: Day 84 or 140
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2012.
- Derived from this study: PubMed 31391226Chachi L, Diver S, Kaul H, Rebelatto MC, Boutrin A, Nisa P, Newbold P, Brightling C. Computational modelling prediction and clinical validation of impact of benralizumab on airway smooth muscle mass in asthma. Eur Respir J. 2019 Nov 14;54(5):1900930. doi: 10.1183/13993003.00930-2019. Print 2019 Nov. No abstract available.
Related trials for Asthma
RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Asthma
Active, not recruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Gossage, M.D., MBA study director
MedImmune LLC
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEDI-563 in people with Asthma, run by MedImmune LLC at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety and tolerability of MEDI-563 in adults with atopic asthma and evaluate the effects of MEDI-563 on eosinophil counts in airway mucosal biopsies 28 days after completion of dosing in adults with atopic asthma. (time frame: Study Day 84 or Day 140 - (dose-driven)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00659659, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2012.